Metastatic Pancreatic CancerPhase 2OPTIMUSNCT04901741
Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer
A Phase 2 study testing Olaptesed pegol and Pembrolizumab in people with Metastatic Pancreatic Cancer, run by TME Pharma AG.
Trial summary
The purpose of this study is to provide a go/no-go decision for a randomized expansion study by assessing the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel, to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Olaptesed pegol and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with confirmed microsatellite-stable tumor pathology, if data available
- Patient with histologically or cytologically confirmed primary metastatic adenocarcinoma of the pancreas, who
- Arm 1: stopped first-line treatment with gemcitabine/nab-paclitaxel after documented objective radiographic progression OR
- Arm 2: stopped first-line treatment with FOLFIRINOX or modified FOLFIRINOX after documented objective radiographic progression
- Measurable disease based on RECIST 1.1 as determined by the investigational site
- Estimated minimum life expectancy 3 months
- Eastern Cooperative Oncology Group (ECOG) performance score 0 to 1
- Adequate organ function laboratory values within the ranges specified: Serum albumin ≥ 3.0 g/dL; Hematological system: Hemoglobin (Hb) ≥ 9.0 g/dL or ≥5.6 mmol/L, Absolute neutrophil count (ANC) ≥ 1,500/mm³, Platelets ≥ 100,000/mm³; Renal system: Creatinine ≤ 1.5 x ULN OR eGFR ≥30 mL/min for patient with creatinine levels >1.5 × institutional ULN; Hepatic system: Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels >1.5 × ULN, ALT and AST ≤ 2.5 x ULN (≤5 × ULN for patients with liver metastases); Coagulation: INR OR PT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Who cannot join
- Prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment.
- Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. Patients with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
- If the patient had major surgery, the patient must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention
- Prior radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and discontinued from that treatment due to a Grade 3 or higher irAE
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
Show all 14Show fewer
- Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines are allowed
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or current pneumonitis / interstitial lung disease
- Active infection requiring systemic therapy
- Known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
- Previous allogeneic tissue/solid organ transplant
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label Phase 2 Study of Olaptesed Pegol (NOX-A12) Combined With Pembrolizumab and Nanoliposomal Irinotecan/5-FU/Leucovorin or Gemcitabine/Nab-paclitaxel in Microsatellite-stable Metastatic Pancreatic Cancer Patients
The purpose of this study is to provide a go/no-go decision for a randomized expansion study by assessing the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel, to assess safety and tolerability and time-to-event endpoints.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Olaptesed pegol, Pembrolizumab
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olaptesed pegolDrug
Also called NOX-A12
400 mg per week as continous infusion until progression or intolerable toxicity
PembrolizumabDrug
Also called KEYTRUDA®
200 mg every 3 weeks as i.v. infusion until progression or intolerable toxicity or a maximum of 35 administrations
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: olaptesed pegol + pembrolizumab + nanoliposomal irinotecan + 5-FU + LV | Experimental | Not described Receives: Drug: Olaptesed pegol; Drug: Pembrolizumab |
| Arm 2: olaptesed pegol + pembrolizumab + gemcitabine + nab-paclitaxel | Experimental | Not described Receives: Drug: Olaptesed pegol; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Go/no-go decision for a randomized expansion study
Assessment of the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel
Measured: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Secondary outcomes (8)
Safety and tolerability
Safety and tolerability of olaptesed pegol pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel
Measured: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
DCR at 12 weeks
Measured: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Progression free survival (PFS)
Measured: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Overall response rate (ORR)
Measured: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
median Overall survival (mOS)
Measured: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Duration of response (DOR)
Measured: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Time-to-best overall response (TBOR)
Measured: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Time-to-next-anticancer-treatment (TTNT)
Measured: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study startJan 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TME Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901741
- Sponsor's protocol ID
- SNOXA12C701
- Other IDs
- 2021-001963-25, KEYNOTE-B01, MK-3475-B01
- Acronym
- OPTIMUS
- Status last verified
- Jun 2025
- First submitted
- 20 May 2021
- Last updated
- 27 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 2 Study of Olaptesed Pegol (NOX-A12) Combined With Pembrolizumab and Nanoliposomal Irinotecan/5-FU/Leucovorin or Gemcitabine/Nab-paclitaxel in Microsatellite-stable Metastatic Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT04901741
- Acronym / sponsor ID
- OPTIMUS / SNOXA12C701
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TME Pharma AGIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide a go/no-go decision for a randomized expansion study by assessing the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel, to assess safety and tolerability and time-to-event endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: olaptesed pegol + pembrolizumab + nanoliposomal irinotecan + 5-FU + LV | Experimental | Drug: Olaptesed pegol, Drug: Pembrolizumab |
| Arm 2: olaptesed pegol + pembrolizumab + gemcitabine + nab-paclitaxel | Experimental | Drug: Olaptesed pegol, Drug: Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with confirmed microsatellite-stable tumor pathology, if data available
- Patient with histologically or cytologically confirmed primary metastatic adenocarcinoma of the pancreas, who
- Measurable disease based on RECIST 1.1 as determined by the investigational site
- Estimated minimum life expectancy 3 months
- Eastern Cooperative Oncology Group (ECOG) performance score 0 to 1
Key exclusion criteria (14 listed)
- Prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment.
- Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. Patients with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
- If the patient had major surgery, the patient must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention
- Prior radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and discontinued from that treatment due to a Grade 3 or higher irAE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olaptesed pegolAlso: NOX-A12400 mg per week as continous infusion until progression or intolerable toxicity | Drug | Arm 1: olaptesed pegol + pembrolizumab + nanoliposomal irinotecan + 5-FU + LV, Arm 2: olaptesed pegol + pembrolizumab + gemcitabine + nab-paclitaxel |
| PembrolizumabAlso: KEYTRUDA®200 mg every 3 weeks as i.v. infusion until progression or intolerable toxicity or a maximum of 35 administrations | Drug | Arm 1: olaptesed pegol + pembrolizumab + nanoliposomal irinotecan + 5-FU + LV, Arm 2: olaptesed pegol + pembrolizumab + gemcitabine + nab-paclitaxel |
Primary outcome
Go/no-go decision for a randomized expansion study
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Assessment of the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel
8 secondary outcomes
Safety and tolerability
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
DCR at 12 weeks
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Progression free survival (PFS)
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Overall response rate (ORR)
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
median Overall survival (mOS)
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Duration of response (DOR)
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Time-to-best overall response (TBOR)
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Time-to-next-anticancer-treatment (TTNT)
Time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olaptesed pegol and Pembrolizumab in people with Metastatic Pancreatic Cancer, run by TME Pharma AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diede van den Ouden (+49-30-166 370 82 0, clinicaltrialdisclosuredesk@tmepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Go/no-go decision for a randomized expansion study (time frame: until progression or intolerable toxicity to completion of 35 administrations (approximately 2 years) with pembrolizumab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.